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Milk Thistle and Liver Disease


[Milk Thistle Action | Milk Thistle Studies in People]
[Cirrhosis Milk Thistle Study | Milk Thistle for Chronic Hepatitis]
[References]

Preliminary studies in animals show that milk thistle may help protect the liver from injury by a variety of toxins ("poisons" such as drugs, viruses, alcohol, radiation, and poisonous mushrooms) and limit the damage from them.1,2 To date, the most reliable milk thistle studies on people show that milk thistle does not cure liver disease, but that milk thistle may improve the way the liver works in patients with cirrhosis.1 However, there is no current evidence to indicate that milk thistle directly affects the Hepatitis C Virus (HCV).

In Germany, where many herbs are regulated and prescribed like drugs, health authorities have approved milk thistle as a complementary treatment (given in addition to conventional drugs) for cirrhosis, hepatitis, and similar liver conditions.2 But a great deal of milk thistle research still is needed before milk thistle therapy could be considered a standard treatment option in the United States.

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Milk Thistle Action

Milk thistle originally is from Europe, but now it also is grown in the United States. Milk thistle's scientific name is Silybum marianum. The milk thistle ingredient that experts believe is responsible for milk thistle's medicinal qualities is called silymarin. Silymarin is found in the fruits of the milk thistle plant. Studies in animals have shown that this milk thistle ingredient promotes the following activities:

Liver Cell Growth—Silymarin from milk thistle appears to promote the growth of some types of cells in the liver.1,2

Antioxidation—Milk thistle Silymarin may be an effective "antioxidant," which means milk thistle may help fight a destructive chemical process in the body known as "oxidation." In oxidation, harmful substances produced in the body (called free radicals) can damage cells. Some studies suggest that milk thistle silymarin can prevent these substances from damaging liver cells.1,3,4

Antihepatotoxic Activity—Studies suggest that silymarin from milk thistle can block various types of toxins from entering and injuring liver cells.1,2,5

Inflammation Inhibition—Milk thistle's Silymarin is thought to prevent inflammation (swelling) of the liver; this may be described as displaying anti-inflammatory properties.1

Milk thistle is not used to prevent Hepatitis C Virus from causing liver disease. Rather, milk thistle is used with the hope that it would minimize the damage to the liver that HCV can cause.

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Milk Thistle Studies in People

Although milk thistle studies in animals provide a good deal of information on potential new treatments, milk thistle studies in humans are needed before it can be determined if these milk thistle therapies are appropriate, safe, and effective in people. The most rigorous type of study to establish a scientific basis for use of a new milk thistle therapy in people is a randomized, double-blind, placebo-controlled (RDBPC) trial.

Cirrhosis Milk Thistle Study

Although not focused primarily on Hepatitis C Virus disease, the most relevant existing research data regarding milk thistle's use as a therapy for hepatitis comes from two RDBPC trials of silymarin's effects on cirrhosis.1 One milk thistle study produced positive results, the second milk thistle study did not corroborate the results in the first milk thistle study. 

The first milk thistle study, reported in 1989, examined 170 patients with cirrhosis from various causes, including alcohol abuse.6 Approximately half (87) of the patients received silymarin from milk thistle (140 milligrams 3 times a day for 2 years). The others (83 patients) received a placebo. Because 24 patients dropped out of the milk thistle study, a total of 146 patients (73 in each group) finished the 2-year milk thistle study.

The doctors in this milk thistle study noted that the number of patients who died in the 4 years after the study was 31 percent lower in the group that received the silymarin from milk thistle than in the group of patients who received the placebo. The beneficial effects of milk thistle silymarin were especially seen in the patients who had cirrhosis as a result of alcohol abuse. The doctors did not report that any patients experienced side effects from milk thistle silymarin treatment.

A more recent RDBPC trial, however, did not find silymarin from milk thistle to have any significant benefits for patients with cirrhosis.7 In this study, reported in 1998, doctors examined 200 patients with cirrhosis caused by alcohol abuse. Approximately half (103) of the patients received milk thistle silymarin (150 milligrams 3 times a day for 2 years). The other half (97) received a placebo. A total of 125 patients (57 in the treatment group and 68 in the placebo group) finished the 2-year milk thistle study. To measure effectiveness, the doctors measured (1) time to death and (2) the worsening of the disease.

Survival was similar in both the milk thistle silymarin and placebo groups, and silymarin from milk thistle did not seem to improve the course of the disease in the treatment group. The doctors who performed the experiment did not note milk thistle side effects in any of the patients.

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Milk Thistle for Chronic Hepatitis

Although small, one randomized controlled trial on hepatitis patients suggests that a specific component in milk thistle silymarin may be beneficial in managing chronic hepatitis.8 In this milk thistle study, reported in 1993, 10 patients with chronic hepatitis were assigned to the milk thistle treatment group and 10 others were assigned to the placebo group. The treatment group received 240 milligrams of silybin, a component of silymarin, two times a day for 1 week. The results of tests that measure how well the liver is functioning showed significant improvement in the milk thistle treatment group, suggesting that silybin may help treat chronic hepatitis.

Milk thistle in the treatment of liver disease needs to be studied further. Fortunately, negative side effects have not yet been reported, and this milk thistle therapy may be much less expensive than conventional drug therapies. Yet, it should be mentioned that conventional therapies have been proven to work in a substantial portion of patients.

Because milk thistle does not dissolve well in water, the herb is not effective in the form of a tea. It currently is marketed in the United States as a dietary supplement in the form of capsules containing 200 milligrams of a concentrated extract with 140 milligrams of silymarin.

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References

1. O'Hara, M., Kiefer, D., Farrell, K., and Kemper, K. "A Review of 12 Commonly Used Medicinal Herbs." Archives of Family Medicine. 1998. 7(6):523-36.

2. Tyler, V.E. "Milk Thistle." In: The Honest Herbal: A Sensible Guide to the Use of Herbs and Related Remedies, 3rd ed., edited by M.C. Smith. Binghamton, NY: Pharmaceutical Products Press, 1993. pp. 209-10.

3. Garciapina, M.P., Perez-Alvarez, V., and Mourelle, M. "Silymarin Protects Against Paracetamol-Induced Lipid Peroxidation and Liver Damage." Journal of Applied Toxicology. 1992. 12(6):439-42.

4. Letteron, P., Labbe, G., Degott, C., Berson, A., Fromenty, B., Delaforge, M., Larrey, D., and Pessayre, D. "Mechanism for the Protective Effects of Silymarin Against Carbon Tetrachloride-Induced Liver Peroxidation and Hepatotoxicity in Mice. Evidence that Silymarin Acts Both as an Inhibitor of Metabolic Activation and as a Chain-Breaking Antioxidant." Biochemical Pharmacology. 1990. 39(12):2027-34.

5. Davila, J.C., Lenherr, A., and Acosta, D. "Protective Effect of Flavonoids on Drug-Induced Hepatotoxicity In Vitro." Toxicology. 1989. 57(3):267-86.

6. Ferenci, P., Dragosics, B., Dittrich, H., Frank, H., Benda, L., Lochs, H., Meryn, S., Base, W., and Schneider, B. "Randomized Controlled Trial of Silymarin Treatment in Patients with Cirrhosis of the Liver." Journal of Hepatology. 1989. 9(1):105-13.

7. Pares, A., Planas, R., Torres, M., Caballeria, J., Viver, J.M., Acero, D., Panes, J., Rigau, J., Santos, J., and Rodes, J. "Effects of Silymarin in Alcoholic Patients with Cirrhosis of the Liver: Results of a Controlled, Double-Blind, Randomized and Multicenter Trial." Journal of Hepatology. 1998. 28(4):615-21.

8. Buzzelli, G., Moscarella, S., Giusti, A., Duchini, A., Marena, C., and Lampertico, M. "A Pilot Study of the Liver Protective Effect of Silybin-Phosphatidylcholine Complex (IdB1016) in Chronic Active Hepatitis." International Journal of Clinical Pharmacology, Therapy, and Toxicology. 1993. 31(9):456-60.

Reprinted with permission from the National Center for Complimentary and Alternative Medicine (NCCAM).  Revised July 25, 2001.

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